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.
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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.
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