Table S3.

Procedure-related adverse events by severity

Severity	Adverse Event	No. subjects with event
Mild	Pain	3
Mild	Skin irritation (soreness, itchiness)	3
Mild	Bleeding (hemorrhage)	1
Mild	Edema (swelling) of tissues or nerves	1
Mild	Change in salivary flow	1
Mild	Numbness	5
Mild	Bruising	1
Mild	Gastrointestinal abnormality	1
Mild	Incision fluid leak, drainage or separation	1
Mild	Muscle or skin tightness	1
Mild	Abnormal scarring (keloid or hypertrophic)	1
Total with at least 1 mild adverse event		12/21
Moderate	Infection	5
Moderate	Pain	1
Moderate	Edema (swelling) of tissues or nerves	2
Moderate	Hematoma	1
Moderate	Nausea/vomiting	3
Moderate	Damage to hypoglossal nerve	1
Moderate	Headache/dizziness	1
Moderate	Lip Weakness	2
Moderate	Muscle or skin tightness	2
Moderate	Musculoskeletal abnormality	1
Total with at least 1 moderate adverse event		12/21
Severe	Infection	1
Severe	Cuff dislodgement	1
Severe	Spinal accessory nerve damage	1
Total with at least 1 severe adverse event		2/21

Adverse events determined by the Clinical Events Committee to be related to the procedure. Totals refer to number of patients with an event (i.e., one subject may have had > 1 event of a given severity).