CellFX ® Percutaneous Electrode (PE) Treatment of Symptomatic Benign Thyroid Nodules

Inclusion Criteria:

• Participant must be at least 18 or no older than 80 years of age

• Participant gives voluntary, written informed consent to participate in thisclinical investigation and from whom consent has been obtained.

• Participant must comply with study procedures including all follow-up visitsdiagnosis of thyroid nodule confirmed by ultrasonography ≤Grade 3 (2017 ACR TI-RADSand fine needle aspiration biopsy FNA (Bethesda category II ) with nomacro-calcifications in target nodule within 30 days of enrollment

• Participant has single nodule ≤ 6.0 cm in greatest dimension.

• Participant may have abnormal thyroid function, such as suppressed thyrotropin (TSH)levels, at the screening visit

• Participant has no abnormal cervical lymph nodes during screening visit examination

• Participant has thyroid nodule causing appearance, pressure or swallowing symptoms

• Participant has absence of abnormal vocal cord mobility by ultrasound evaluation

Exclusion Criteria:

• Participant has an implantable electronic medical device. (i.e., pacemaker,implantable cardioverter defibrillator)

• Participant has an active systemic infection on the day of the CellFX PE procedurewith either fever, leukocytosis or requiring intravenous antibiotics or history ofhead and neck, pulmonary or systemic infection in the last 2 weeks prior to CellFXPE procedure

• Participant is known to be immune compromised

• Participant is a member of a vulnerable population including individuals employed bythe Sponsor, clinic site, or entity associated with the conduct of the study

• Participant had previous neck irradiation

• Participant has history of familial thyroid cancer in more than two first-degreerelatives

• Participants currently suffering from hematological diseases or bleeding tendency,or patients currently requiring continuous administration of antiplatelet andanticoagulant drugs

• Ultrasonographic evidence of calcifications, irregular margins or sonographicfeatures that are suspicious for malignancy

• Nodule likely to be in contact with the recurrent laryngeal nerve on ultrasoundevaluation

• History of cardiac arrhythmia, uncontrolled hypertension, liver or kidney disease,or recent history of myocardial infarctions or structural heart disease asdetermined by the Investigator

• History of a coagulation mechanism disorder or bleeding tendency

• Abnormal contralateral vocal cord function

• Allergy or contraindication to assigned analgesia/anesthesia

• Females of childbearing potential who are nursing, pregnant, or planning to becomepregnant during the study period

• Have any condition or situation which, in the Investigator's opinion, puts theparticipant at significant risk, could confound the study results, or may interferesignificantly with the participant's participation in the study

• Use of any other investigational drug, therapy, or device within 30 days prior toenrollment or concurrent participation in another research study