MAUDE Adverse Event Report: UNITED STATES ENDOSCOPY GROUP, INC. 16 FR CRYODECOMPRESSION TUBE

Model Number	CC301
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Codes	Hematemesis (4478); Insufficient Information (4580)
Date of Event	05/23/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that their trufreeze system was not operating properly during a patient procedure.Additional medical treatment was administered following the procedure.
Additional Manufacturer Narrative
The log files for the trufreeze system subject of the reported event were reviewed by the service specialist.No abnormalities were observed with the log files; the trufreeze system had operated to specifications.No issues were noted.The doctor who performed the patient procedure accepted in-service training with steris's chief medical officer for the trufreeze system.A follow-up report will be submitted when additional information is available.No additional issues have been reported.
Additional Manufacturer Narrative
Following treatment with the trufreeze system, the patient experienced nausea and several episodes of small volume hematemesis, necessitating hospitalization.Ct chest showed trivial subcutaneous emphysema and small bilateral pleural effusions.Two units of red blood cells were given and the patient remained hemodynamically stable throughout the hospital stay.An upper endoscopy performed approximately 2 days later showed long linear ulcers in the proximal third of the stomach and expected ulceration at the treatment site.The patient has been discharged.The log files for the trufreeze system subject of the reported event were reviewed by the service specialist.No abnormalities were observed with the log files; the trufreeze system had operated to specifications.Through follow up with the steris chief medical officer (cmo), we learned the patient's medical history included superficial esophageal squamous cell carcinoma which was treated previously with endoscopic resection.Spray cryotherapy was used in this case to treat residual squamous dysplasia after the endoscopic resection.The steris cmo and the treating physician reviewed the case and determined the patient presentation and medical history were contributing factors to the event.The instructions for use for the trufreeze system states "the physician should carefully consider the patient eligibility for cryospray ablation (i.E.Cyrosurgery and associated gas pressure), including patient presentation, medical history, comorbidities (e.G.Copd, cad), and prolonged use of steroids that may reduce the patient's tissue compliance and tissue strength affecting their ability to tolerate cryospray." the steris cmo performed in-service training on the use and operation of the trufreeze system with the treating physician subject of the reported event.No additional issues have been reported.

• Brand Name: 16 FR CRYODECOMPRESSION TUBE
• Common Device Name: 16 FR CRYODECOMPRESSION TUBE
• Manufacturer (Section D): UNITED STATES ENDOSCOPY GROUP, INC.; 5976 heisley road; mentor OH 44060
• Manufacturer (Section G): UNITED STATES ENDOSCOPY GROUP, INC.; 5976 heisley road; mentor OH 44060
• Manufacturer Contact: coletta cohara ; 5976 heisley road; mentor, OH 44060 ; 4403586251
• MDR Report Key: 14803500
• Report Number: 1528319-2022-00035
• Device Sequence Number: 4677336
• Product Code: GEH
• UDI-Device Identifier: 00857068006075
• UDI-Public: 00857068006075
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/24/2022

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: Health Professional
• Device Model Number: CC301
• Device Catalogue Number: CC301
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/26/2022
• Supplement Date Received by Manufacturer: 05/26/2022
• Initial Report FDA Received Date: 06/24/2022
• Supplement Report FDA Received Date: 09/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/01/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown