MAUDE Adverse Event Report: C2 THERAPEUTICS, INC. C2 CRYOBALLOON ABLATION SYSTEM; CRYOSURGICAL UNIT WITH ACCESSORIES

Model Number	FG-1009, FG-1012
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Stenosis (2263)
Date of Event	01/20/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned for analysis and could not be further investigated.Based on the information reported from the physician, the device appears to have functioned as intended.
Event or Problem Description
During the (b)(6) 2016 procedure, 11 ablations were performed.The patient reported a pain score of 4 (1 to 10 scale) on day 1 and 0 on day 7.On (b)(6) 2017, the patient came to the emergency room with difficulty swallowing for 3 days.An endoscopy was performed and showed a benign appearing esophageal stenosis that was dilated.The patient's symptoms improved, but he was unable to consume a normal diet through 4 days post dilation.An endoscopy was performed on (b)(6) 2017.There was a severe benign stenosis.The stricture had a 6 mm diameter and 1 cm length.Coagulation for tissue destruction using a monopolar probe (it2 knife) was performed.Dilation with a 15-16.5-18 mm x 5.5 cm cre balloon dilator was performed to 16 mm, and the area was injected with 80 mg of triamcinolone (40 mg/ml, diluted up to 5 ml).The stomach and duodenum were normal.The patient is scheduled for repeat upper endoscopy in 1 month for retreatment.The physician stated that, "the strictures will occur after any mucosal ablating therapy, this event is not life-threatening and as such i would like to wait and see the complete update in 2 weeks.".

• Brand Name: C2 CRYOBALLOON ABLATION SYSTEM
• Common Device Name: CRYOSURGICAL UNIT WITH ACCESSORIES
• Manufacturer (Section D): C2 THERAPEUTICS, INC.; 303 convention way; suite 1; redwood city CA 94063
• MDR Report Key: 6361363
• Report Number: 3008780134-2017-00003
• Device Sequence Number: 799126
• Product Code: GEH
• UDI-Device Identifier: 00854924006095
• UDI-Public: 00854924006095
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K161202
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Physician
• Device Expiration Date: 06/28/2018
• Device Model Number: FG-1009, FG-1012
• Device Catalogue Number: FG-1009, FG-1012
• Device Lot Number: 06092016-01
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/01/2017
• Initial Report FDA Received Date: 02/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other