Study: NCT04185909

Adverse event: Intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Notes: The subject was admitted to the hospital for bowel obstruction. After Investigator review, this event was identified to be secondary to prior bowel cancer that was not reported by subject at baseline. This is not related to study device or procedure.
Frequency: 1 affected / 55 at risk

Adverse event: Erythema/skin inflammation/ focal skin congestion (Expected Treatment Effect)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 55 affected / 55 at risk

Adverse event: Crusting (Expected Treatment Effect)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 55 affected / 55 at risk

Adverse event: Edema/Swelling (Expected Treatment Effect)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 55 affected / 55 at risk

Adverse event: Pain/Tenderness (Expected Treatment Effect)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 30 affected / 55 at risk

Adverse event: Milia/acne
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 16 affected / 55 at risk

Adverse event: Pruritus/itching (Expected Treatment Effect)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 14 affected / 55 at risk

Adverse event: Hypertrophic scarring
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 55 at risk

Adverse event: Post-inflammatory hyperpigmentation (Expected Treatment Effect)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 55 at risk

Adverse event: Telangiectasias
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 55 at risk

Adverse event: Discoloration/hypopigmentation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 55 at risk

Adverse event: Pinpoint Bleeding (Expected Treatment Effect)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 55 at risk

Adverse event: Prolonged Wound Healing
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 55 at risk

Adverse event: Urticaria/rash (Expected Treatment Effect)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 55 at risk

Adverse event: Eye irritation
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 55 at risk

Adverse event: Nausea during Procedure
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 55 at risk

Adverse event: Emesis/Vomiting Post-Procedure
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 55 at risk

Adverse event: Drug Reaction During Procedure
Serious: no
Organ System: General disorders
Frequency: 1 affected / 55 at risk

Adverse event: Lower Lid Retraction
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 55 at risk

Adverse event: Intestinal obstruction
Serious: no
Organ System: Gastrointestinal disorders
Notes: Unrelated to device/procedure
Frequency: 1 affected / 55 at risk

Adverse event: Self-Inflicted Superficial Excoriations
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 55 at risk