TABLE 4.

Adverse Events^* through One-Month Follow-up (Primary and Secondary End Points)

Outcome		n/N subjects (%) [n events]
Composite rate of all adverse events related to the ablation device (primary endpoint)†		1/30 (3.3) [1] (Hemoptysis)
Composite rate of all serious adverse events related to the ablation device†		0/30 (0.0) [0]
Composite rate of all adverse events related to the study procedure or study devices (including events related to anesthesia and the entire bronchoscopic procedure)		21/30 (70.0) [51]
CTCAE Grade <3 (detailed below)‡		20/30 (66.7) [42]
Bradycardia§		1/30 (3.3) [1]
Chest discomfort		2/30 (6.7) [2]
Cough		2/30 (6.7) [2]
Dyspnea		7/30 (23.3) [7]
Hemoptysis		5/30 (16.7) [5]
Lower respiratory tract infection		2/30(6.7) [2]
Oropharyngeal pain		3/30 (10) [3]
Pleural effusion		2/30 (6.7) [2]
Pleural thickening		1/30 (3.3) [1]
Postablation syndrome		1/30 (3.3) [1]
Procedural pain		13/30 (43.3) [15]
Unwanted awareness during anesthesia		1/30 (3.3) [1]
CTCAE Grade 3		4/30 (13.3) [9]
Composite rate of all serious adverse events related to the study procedure or other study devices (detailed below)‖		4/30 (13.3) [9]¶
Subject	Event(s)	Description
1	Postablation syndrome	The patient developed a fever of 38°C while still in the hospital the day after ablation and was kept in the hospital overnight for observation.
	Postprocedure pleuritic chest pain	Right pleuritic chest pain on the day after ablation. Treated with a standard dose of paracetamol, tramadol, and Voltaren SR for pain control during hospitalization.
	Ablation site infection	The patient was admitted to the emergency room with fever on day 6 after ablation. Sputum culture was positive for Acinetobacter the following day. The patient was admitted and treated with intravenous ampicillin and sulbactam.
2	Pleural effusion	The ablation zone involves the visceral pleura. The patient developed right pleural effusion on day 2 while still in the hospital after the study procedure. The patient was treated with oxygen a nasal cannula and drainage with a 12 French catheter.
3	Postprocedure pleuritic chest pain	The patient complained of chest pain on day 4 postprocedure, thought to be the result of inflammation (below) and worsened by cough induced by postnasal drip from allergic rhinitis.
	Pleuritis	Postablation pleural inflammation (day 16 postprocedure) with no evidence of infection.
	Hemoptysis	Blood-stained sputum treated with oral transamin
4	Breathlessness	The patient experienced 2 weeks of breathlessness postprocedure and was admitted for ultrasound-guided effusion drainage and COPD treatment.
	Pleural effusion	One-month follow-up CT showed small pleural effusion.

Data are presented as n/N (%) [n events]

^*Adverse events are defined according to ISO 14155:2011 as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) whether or not related to the investigational medical device.

^†The Emprint Ablation Catheter Kit with Thermosphere Technology

^‡Patients may have had more than one event. CTCAE Grades are as follows:¹⁸

Grade 1: Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated.

Grade 2: Moderate; minimal, local, or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living.

Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living.

^§The adverse event was self-limiting and occurred during the inspiratory breath hold for CBCT.

^‖Other study devices may include, but are not limited to, the navigation system, the locatable guide, the extended working channel, transbronchial access tools and other endoscopic tools. There were no serious adverse events related to the Emprint Ablation Catheter Kit with Thermosphere Technology.

^¶A total of 9 serious adverse events (all rated as CTCAE Grade 3) related to the study procedure or other study devices occurred in 4 subjects.

COPD indicates chronic obstructive pulmonary disease; CT, computed tomography; CTCAE, Common Terminology Criteria for Adverse Events.