Table 2.

Serious Adverse Events

Event Type	Treatment Recovery Period* (n Events)	3 mo† (n Events)	6 mo‡ (n Events)	12 mo§ (n Events)
Device-related‖	0	0	0	0
Procedure-related‖
COPD exacerbation	1	1	0	0
Mucosal scarring	1	0	0	0
Pneumonia	1	0	0	0
Unrelated to device or procedure
Atrial fibrillation	1	0	0	0
COPD exacerbation	0	1	1	3
Erysipelas	0	0	1	0
Femoral artery stenosis	0	0	1	1
Lung nodule	0	0	0	1
Musculoskeletal injury	0	0	0	1
Pyelonephritis	0	0	0	1

Definition of abbreviation: COPD = chronic obstructive pulmonary disease.

There were a total of 16 events in 11 patients. One patient experienced 2 COPD exacerbations in separate time intervals.

^*Thirty days after either bronchial rheoplasty procedure.

^†Follow-up period through 3 months after treatment 2, excluding either treatment recovery period.

^‡Follow-up period between 3 months and 6 months after treatment 2.

^§Follow-up period between 6 months and 12 months after treatment 2.

^‖Events are considered device-related or procedure-related if judged by the treating investigator to be possibly, probably, or definitely related to the device or procedure, respectively.