MAUDE Adverse Event Report: C2 THERAPEUTICS CRYOBALLOON ABLATION SYSTEM; CRYOSURGICAL UNIT WITH ACCESSORIES, PRODUCT CODE: GEH

Model Number FG1012

Device Problems Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)

Patient Problems Dysphagia/ Odynophagia (1815); Vomiting (2144); Stenosis (2263); Laceration(s) of Esophagus (2398)

Event Date 01/04/2018

Event Type  Injury  

Manufacturer Narrative

Stricture or narrowing of the esophagus is a known and anticipated adverse event after an endoscopic therapy procedure for treatment of barrett's esophagus.This stricture is probably related to the procedure.

Event Description

On august 2, 2017, c2 therapeutics was informed of an adverse event.After the initial procedure, a (b)(6) study participant was diagnosed with narrowing of the esophagus (stricture) on (b)(6) 2017.The patient had complained of difficulty swallowing and was vomiting food.The patient was also experiencing abdominal pain; this was not reported as serious.There were no issues noted with the device.An attempt to obtain the actual device and a lot number was unsuccessful as the site did not note the device information.

Event Description

C2 therapeutics became aware of esophageal laceration on (b)(6) 2018.- initial report referenced in mdr 3008780134-2017-00012.Serious adverse event type: laceration (non-transmural tear) of the esophagus requiring treatment.The subject was scheduled for a 6-month follow up esophagogastroduodenoscopy (egd) on (b)(6) 2018.He had complained of moderate passage: able to eat some solid foods and identified a 5 on pain scale.During the beginning of the procedure "one moderate benign-appearing, intrinsic stenosis was found 36cm from the incisors".This measured 9 mm (inner diameter) and was traversed after dilation.A through the scope (tts) dilator was used to treat the stenosis.Post dilation a deep laceration was observed; 3 endoclips were placed to close that laceration.No cryotherapy procedure was performed during this follow-up egd.The patient was administered antibiotics and kept nothing by mouth (npo) and was admitted to the hospital ward for observation.The subject was discharged on (b)(6) 2017 12:00 pm.A follow up egd is scheduled for the middle of (b)(6) 2018.

Manufacturer Narrative

This is a supplemental/follow-up report for mdr 3008780134 2017 00012 based on additional information provided by the physician.The subject was initially treated with cryoballoon system on (b)(6) 2017.Subject subsequently was treated twice for symptoms related to stricture, on (b)(6) 2017 and (b)(6) 2017.In both instances, symptoms resolved after dilation treatment with a through-the-scope (tts) 15-16.5-18mm balloon dilator.Post cryoballoon ablation, the treating physician reported a stricture that was procedure related.During the 6-month follow up egd a moderate, benign-appearing intrinsic stenosis was observed and dilation was performed using a balloon dilator.Post dilation, a deep laceration was observed.Because the laceration was discovered post dilation, it appears that the laceration occurred as a result of the dilation procedure.It was also reported that the physician did not attempt cryoballoon treatment during this follow up visit, therefore, c2 device was not used and actual device evaluation could not be performed.Per request from fda on 26mar2020, supplemental report was submitted with incorrect report number.This report is being submitted to correct the report number from 3008780134-2018-00002 to 3008780134-2017-00012 note: the following code/s on previous follow-up no longer available.3263-actual device not evaluated.

• Brand Name: CRYOBALLOON ABLATION SYSTEM
• Type of Device: CRYOSURGICAL UNIT WITH ACCESSORIES, PRODUCT CODE: GEH
• Manufacturer (Section D): C2 THERAPEUTICS; 303 convention way, ste 1; redwood city CA 94063
• MDR Report Key: 6822474
• MDR Text Key: 83726576
• Report Number: 3008780134-2017-00012
• Device Sequence Number: 1
• Product Code: GEH
• Combination Product (y/n): N
• PMA/PMN Number: K161202
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: FG1012
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/05/2018
• Patient Sequence Number: 1
• Patient Outcome(s): Other